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Abstract:

A treatment delivery system includes one or more medical therapy delivery
devices (34) which deliver medical treatment or therapy to a patient, and
one or more medical devices (10) which monitor results of the delivered
medical therapy or treatment, clinical information, laboratory
information, and health record information. The medical treatment
delivery device has a proprietary communications protocol. A medical
therapy delivery controller (18) semantically communicates among the
medical device(s) and one or more medical treatment delivery devices. The
controller has a user input (32) by which a user inputs therapy
objectives in other than the proprietary communications protocol and a
control processor (26) which generates treatment delivery device control
commands, receives treatment or therapy results from a medical device
(10), and adaptively adjusts the control commands based on the received
treatment results. The control processor accesses a clinical decision
support system (41), determines a physiological state of the patient from
the received treatment results, and adjusts one of the therapy objectives
and the control commands in accordance with input from the clinical
decision support system.

Claims:

1. A medical treatment delivery controller which controls operation
settings of a medical treatment delivery device, which has a proprietary
communications protocol, the controller comprising: a user input by which
a user inputs therapy objectives in other than the proprietary
communications protocol; a control processor which generates treatment
delivery device control comments, receives treatment results from a
medical device minimally based on a therapy epoch, and adaptively adjusts
the control commands based on the received treatment results.

2. The controller according to claim 1, wherein the control processor
further accesses a clinical decision support system, determines a
physiological state of the patient from the received treatment results,
and adjusts one of the therapy objectives and the control commands in
accordance with input from the clinical decision support system.

3. A treatment delivery system comprising: one or more medical treatment
delivery devices; one or more medical device; and the medical treatment
delivery controller according to claim 1.

4. A medical therapy delivery system comprising: a treatment delivery
device which delivers medical treatment to a patient; a medical device
which collects data regarding results of the delivered medical treatment;
a controller which receives a semantic communication about the patient,
the semantic communication including the results of the medical treatment
and a therapy objective for the patient and adaptively adjusts operation
settings of the treatment delivery devices based on the semantic
communication.

5. The system according to claim 3, wherein the medical device receives
at least one of metabolic parameters, physiological parameters, clinical
information, laboratory information, and health record information
indicative of a current physiological state of the patient, further
including: a clinical decision support system which adapts at least one
of the therapy objective and the delivered treatment in accordance with
the received at least one of the patient's current physiological state,
clinical information, laboratory information, and health record
information.

6. The device according to claim 3, further including: a user input by
which a user inputs instructions to the controller such that the user
shares control of the treatment delivery device.

8. The device according to claim 3, wherein the controller adjusts closed
loop and partial closed loop settings of the treatment delivery device.

9. The device according to claim 3, wherein the therapy objective
includes at least one of: data relating to the medical device's delivery
of medical therapy to the patient including the relationship of various
operation settings, acceptable ranges and parameters, and how the
selected operation settings should vary with changes in the patient's
physiological state.

10. A method for semantic communication between a plurality of medical
devices in which two devices participating in a common therapy
communicate semantically, the method comprising: with a medical device,
collecting results indicative of effects of the therapy on at least one
of the patient's metabolic or physiological state, clinical information,
laboratory information, and health record information of a patient who is
receiving the medical therapy; with one or more medical treatment
delivery devices, delivering the medical therapy to the patient in
accordance with a therapy objective; communicating semantically among the
medical device and the medical treatment delivery devices and the therapy
objective, the semantic communication including the results of the
medical therapy and the therapy objective for the patient based on at
minimum a therapy epoch; adjusting one or more operational settings of
one or more of the medical treatment delivery devices based on the
semantic communication.

11. The method according to claim 10, further including: comparing the
collected results and the therapy objective to determine if the results
of the medical therapy are within limits and parameters of the therapy
objective using a clinical decision support system such that the therapy
objective is correlated with the patient's current metabolic or
physiological state.

12. The method according to claim 10, wherein adjusting the operation
settings includes automatically adjusting a closed loop and partial
closed loop setting of the medical treatment delivery devices.

13. The method according to claim 10, further including: collecting
delivery results of the one or more medical treatment delivery devices.

14. The method according to claim 10, wherein the therapy objective
includes at least one of: data relating to the medical treatment delivery
device's delivery of medical therapy to the patient. including the
relationship of various operation settings, acceptable ranges and
parameters, and how the selected operation settings should vary with
changes in the patient's metabolic or physiological state.

16. The method according to claim 10, further including: displaying an
alarm on a display if the results of the medical therapy are outside the
limits and parameters of the therapy objective.

17. A computer readable medium containing software which when loaded into
a processor programs the processor to control a monitoring device and one
or more medical delivery treatment devices to perform the method
according to claim 10.

Description:

[0001] The present application relates to a system and method for semantic
communication of device data between a source and a receiving client. It
finds particular application in improving the communication semantics of
medical therapy delivery or monitoring devices and will be described with
particular reference thereto.

[0002] Presently, various medical devices such as ventilators, medication
and nutrition administration devices (i.e. feeding or IV pumps),
pacemakers, body temperature controllers, anesthesia delivery, home
monitoring, photo therapy, image system gating, and the like, communicate
between each other in a variety of proprietary and open communication
schemas when delivering therapy to a patient. Many manufacturers of these
devices use different naming conventions (nomenclature) to represent the
method and modes by which they deliver therapy to differentiate their
devices when in fact they are delivering the same therapy. In addition,
these medical devices have sophisticated controls which permit numerous
details of the delivery to be selected. The differences in the way these
devices represent the method and modes by which they deliver therapy
produce unsafe and ambiguous environments between therapy objective and
the patient machine interface. Because of this, there is difficulty in
conveying the intent of the clinician, particularly as modified in light
of current physiological conditions of the patient, to the detailed
control of the device(s).

[0003] Problems also exist when such devices are used in conjunction with
each other in closed loop or partial closed loop control and safety
interlock configurations. In such configurations, the devices must
understand the same semantics in order to provide a safe therapy
environment and complete situational awareness. In many cases, the data
communicated from one device needs to be translated to an ontology that
the other device understands, which can produce ambiguous communication
between the devices resulting in unsafe therapy conditions.

[0004] The present application provides a new and improved method for
semantic communication for device data between a source and a receiving
client which overcomes the above-referenced problems and others.

[0005] In accordance with one aspect, a medical therapy delivery
controller is provided. The controller controls operation settings of a
medical therapy delivery device which has a heterogeneous or proprietary
communication protocol. The controller includes a user input by which a
user inputs therapy objectives in other than the proprietary
communications protocol. The controller also has a control processor
which generates therapy delivery device control commands, receives
treatment results from another medical device or patient monitor, and
adaptively adjusts the control commands based on the received treatment
results. The control processor may be either in the medical device or
monitor, or in another unit.

[0006] In accordance with another aspect, the control processor further
accesses a clinical decision support system. The control processor
determines a physiological state of the patient from the received
treatment results and adjusts at least one of the therapy objectives and
the control commands in accordance with input from the clinical decision
support system.

[0007] In accordance with another aspect, a treatment delivery system is
provided which includes at least one treatment delivery device that
delivers medical treatment to a patient, at least one device which
monitors the results of the delivered medical treatment, and at least one
medical therapy delivery controller.

[0008] In accordance with another aspect, a method of semantic
communication between a plurality of medical devices, in which at least
two devices are participating in a common therapy, communicate
semantically. The results of medical treatment of a patient who is
receiving delivered medical therapy or treatment are collected with a
monitoring device. The results are indicative of the effects of the
therapy on the patient's physiological state. One or more medical
treatment delivery devices delivery medical therapy to the patient in
accordance with a therapy objective communicating semantically among the
monitoring and medical treatment delivery devices and the therapy
objective, the semantic communication including the results of the
medical therapy and the therapy objective for the patient. One or more
operational settings of the one or more medical treatment delivery
devices is adjusted based on a semantic communication(s).

[0009] One advantage resides in clear conveyance of the therapy objective
of the clinician to the detailed control of the patient device
interface(s).

[0010] Another advantage resides in providing safe and unambiguous
environments between the therapy objective and the patient device
interface during the delivery of therapy.

[0011] Another advantage resides in the unambiguous communication of
device data between a plurality of patient device interfaces.

[0012] Still further advantages of the present invention will be
appreciated to those of ordinary skill in the art upon reading and
understand the following detailed description.

[0013] The invention may take form in various components and arrangements
of components, and in various steps and arrangements of steps. The
drawings are only for purposes of illustrating the preferred embodiments
and are not to be construed as limiting the invention.

[0015] FIGS. 2A-2D illustrate four examples of semantic communication for
a ventilator;

[0016] FIG. 3 is a flowchart illustrating operation of the system;

[0017]FIG. 4 is a flowchart illustrating operation of the system; and,

[0018] FIG. 5 illustrates a ventilator feedback controller.

[0019] While the present disclosure of a system and method for semantic
communication is illustrated as being particularly applicable to a
ventilator interface, it should be appreciated that the present
disclosure can be applied to any medical therapy delivery or medical
monitoring device which has a series of settings, driving function, and
device and/or patient results from the therapy device, such as IV or
medication or nutrition administration systems, pacers/defibrillators,
thermal control systems, anesthesia delivery systems, and the like.

[0020] In a preferred embodiment, a system and method for semantic
communication is illustrated which is able to communicate between various
medical devices such that the relationships of expected device settings
and observed patient results are based on common base functions
(primitives), relationships between, and transfer functions relating to
the primitives. The semantic communication allows each therapy epoch or
event, such as a patient's breath, to be broken down into an array of
implicit or explicit primitives and transfer functions describing the
intended relationship of primitives and the actual delivered results. In
order to facilitate semantic understanding of the primitives and transfer
functions between various medical devices, the primitives and transfer
functions are named or tagged based on a harmonized naming standard or a
particular medical device manufacturer naming standard.

[0021] For example, in the case where a clinician wants to control at a
high level the delivery of therapy from a ventilator, the clinician would
select the delivered oxygen volume, flow rate, pressure, and the like
being delivered to the patient. The clinician would also input statements
relating to the various primitives, such as gas flow, volume, and
pressure, how the selected primitives should relate to each other,
acceptable ranges, over time, and how the selected primitives should vary
with changes in the patient's physiological state, and the like. From the
combination of the statements, primitives, and measurements of the
patient's physiological state, transfer functions are generated. In the
ventilator example, the transfer function may be the difference between
the intent of the medical therapy and the actual delivery of oxygen in
each breath. Open, partial, and closed feedback loops modify the
operating parameters of the ventilator in order to maintain the delivery
of oxygen to the patient, or CO2 removal from the patient, within the
limits and parameters set forth by the clinician, while maintaining other
cardiovascular or physiologic parameters within acceptable limits,
through the use of the statements and primitives.

[0022] Such a system and method for semantic communication is particularly
advantageous in a medical treatment delivery system as shown in FIG. 1.
With reference to FIG. 1, a patient (not shown) interacts with various
medical devices 10 that measure physiological parameters of the patient
and generate physiological data indicative thereof, clinical information,
laboratory information, medication administration, historical
physiologic, and other health record information. These medical and
information devices 10 may include an electrocardiographic (ECG)
instrument with internal or surface ECG electrodes, IV fluid or
medication or nutrition pumps, pleural pressure, blood pressure,
abdominal pressure, and cardiac output sensors, SpO2 sensors, SO2 and
SaO2 sensors, pH sensors, PaO2 sensors, FIO2 sensors, ETCO2 sensors,
pulse sensors, thermometers, respiratory sensors, exhaled gas sensors,
other therapy measures and the like. The medical monitoring devices may
also include ventilator time, flowmeters, resistance and compliance
sensors, gas mixture and pressure sensors to measure patient airway
pressure, flow and resistance in the case of ventilation therapy.

[0023] Other therapy applications have other medical and information
devices in use. For example, if cardiac pacing is the therapy application
in mind, the epoch is each cardiac beat. The intended therapy can be
related to cardiac output, ejection fraction, preload, or other inputs
such as patient assessment of dyspnea or shortness of breath. The therapy
primitives can be pace pulse impulse duration, timing, current, waveform
characteristics, and the like. Primitives can be interval and segment
measures related to each ECG lead, maximum and minimum ST location,
conduction vectors, beat to beat averages and wave pattern morphology,
and overall beat to beat pressure wave timing, morphology, and perfusion
flow.

[0024] Another therapy application to which to this semantic approach can
be applied is thermal regulation and therapeutic hypothermia. In this
case the therapy epoch is defined as duration based on the reason for
therapeutic hypothermia. In this application, the primitives include core
temperature, cooling trajectory, target temp, expected duration, as well
as metabolic and physiologic feedback such as lactate, O2 consumption,
and EEG activity to name a few.

[0025] Other medical devices 10 can be associated with a patient, and not
all of the above-mentioned medical devices 10 have to be associated with
a patient at any given time. It should be appreciated that while only two
medical devices 10 are illustrated, more medical monitoring devices or
health record laboratory findings, medication administration or other
clinical information and devices are contemplated. As used herein,
medical monitoring devices signify data sources indicating patient
health, treatment delivery device status, or the like. Sensors for
receiving signals from the medical device 10 and for optionally
performing signal processing on such signals are embodied in the
illustrated embodiment as a multi-functional patient monitor device 12,
or may be embodied partly or wholly as on-board electronics disposed with
one or more of the medical devices 10 or so forth. It should also be
appreciated that the medical devices 10 and the patient monitor 12 could
also be embodied into a single device. The patient monitor 12, for
example, may be a monitor that travels with the patient, such as the
transmitter of an ambulatory patient worn monitoring system, or the like.

[0026] The medical devices 10 transmit the generated physiological data
via a body coupled network, Zigbee, Bluetooth, wired or wireless network,
or the like to a controller 14 of the patient monitor 12. The patient
monitor 12 serves as a gathering point for the physiological data
measured by the medical devices 10, and provides temporary storage for
the data in a memory 16. The collected physiological data is concurrently
transmitted to a controller 14 in the patient monitor 12 which then
transmits the physiological data in a semantic communication to a
ventilator controller 18 where the physiological data is displayed and
stored. The semantic communication contains information relating to the
intent of the medical therapy and information relating to the results of
the delivered therapy. The semantic communication also includes an array
of implicit or explicit primitives and transfer functions describing the
intended relationship of primitives and the actual delivered results,
such as the physiological data.

[0027] Optionally, a communication unit 20 controlled by the controller 14
transmits the physiological data in the semantic communication to the
ventilator controller 18. The controller 14 of the patient monitor 12
also controls a display 22 to display the measured physiological data
received from each of the medical monitoring devices 10 in the patient
monitor display 22. The patient monitor 12 also includes an input device
24 that allows the clinical operator or user, such as a system
administrator, to view, manipulate, and/or interact with the data
displayed on the display 18. The input device 24 can be a separate
component or integrated into the display 18 such as with a touch screen
monitor. The controller 14 may include a processor or computer, software,
or the like.

[0028] A control processor 26 of the ventilator controller 18 receives the
semantic communication from the patient monitor 12 and stores the
physiological data in a memory 28. The control processor 26 also controls
a display 30 of ventilator controller 18 to display the physiological
data received from the patient and the semantic communication received
from the patient monitor 12 in the display 30. The control processor also
forwards the physiological data to a clinical decision system (CDS). The
ventilator controller 18 also includes an input device 32 that allows a
clinician to input various ventilator settings and the objectives or
intent of the medical therapy of the patient on a ventilator 34 using
generic terminology. The ventilator settings include delivered oxygen
volume, flow rate, pressure, open loop setting, closed loop setting,
partial closed loop settings, and the like being delivered to the
patient. The ventilator settings also include the different modes of
ventilator operation including continuous positive airway pressure,
synchronized intermittent mandatory or machine ventilation, and the like.
The clinician may also input, using the input device 32, statements
native to the device, relating to various primitives, such as flow,
volume, and pressure, how the selected primitives should relate to each
other, acceptable ranges, and how the selected primitives should vary
with changes in the patient's physiological state, and the like. The
input device also allows the user, such as administrative personal, to
view, manipulate, and/or interface with the data displayed on the display
30. The input device 32 can be a separate component or integrated into
the display 30 such as with a touch screen monitor. One example of the
input includes: "maintain SpO2>x % while minimizing Fio2 to 0.35, and
PSV to 5 cmH2O to a max of FiO2 85% and PSV 27 cmH2O according to the
Fio/SpO2 function F(FiO2/SpO2(t))=blabla, and F(FiO2/PSV (t))=blablabla".

[0029] The inputted ventilator settings and the intent of the medical
therapy are concurrently transmitted to the control processor 26 in the
ventilator controller 18 which then transmits the ventilator settings and
the intent of the medical therapy in a semantic communication to a
controller 36 in a ventilator 34 which has a proprietary communications
protocol. The control processor adapts the generic (or proprietary) input
from the monitor and the generic objectives from the input 32 into
appropriate control commands for the ventilator or other treatment
delivery device. Although shown as separate functions, it is to be
appreciated that these functions can be performed by a common processor
or controller. Optionally, a communication unit 38 controlled by the
control processor 26 transmits the ventilator settings and the intent of
the medical therapy in the semantic communication to the ventilator 34.
The control processor 36 of the ventilator 34 controls a pneumatic system
38 to control the flow and pressure of gas delivered from a gas source 40
to a patient's airway in accordance with the ventilator settings and of
the intent of the medical therapy. It should also be appreciated that the
ventilator 34 and the patient monitor 12 could be partially or fully
embodied into a single device. The ventilator 34, for example, may be a
ventilator 34 which measures one or more of the physiological parameters
of the patient which transmits the physiological data in a semantic
communication to the ventilator controller 18, or the like.

[0030] The control processor 26 of the ventilator controller 18 compares
the intent of the medical therapy and the results of the delivered
medical to determine if the results from the delivered therapy are within
the parameters and limits of the intent of the medical therapy. If the
results of the delivered medical therapy are not within the parameters
and limits of the intent of the medical therapy, the control processor 26
of the ventilator controller 18 adjusts the closed loop and partial
closed loop settings of the ventilator 34 in order for the results of the
delivered medical therapy to be within the limits and parameters of the
intent of the medical therapy. Control settings may also be changed if
the controller determines that a more optimal set of feedback values can
be achieved within constraints defined by the statement of therapeutic
intent (this is commonly referred to as "optimization", for example, to
achieve a maximal flow rate at the lowest positive pressure in a given or
variable period of time). The control processor 26 also accesses a
clinical decision support system (CDS) 41, which may be internal to the
ventilator controller 18, to the patient monitor (12) or external to both
devices. The CDS adapts the therapy objectives or the ventilator control
commands in accordance with best medical practices for a patient with the
patient's current physiological or clinical state or upon gaining new
knowledge, such as clinical history, laboratory information, medication
administration, and other health record information. In this manner, the
therapy adapts or evolves as the patient's physiological state improves
or deteriorates over time. The control processor 26 also controls the
display 30 of the ventilator controller 18 to display an alarm condition
when the results from the delivered medical therapy are not within the
parameters and limits of the intent of the medical therapy to indicate
that clinician intervention is required.

[0031] Optionally, a feedback controller 42 of the ventilator controller
18 compares the intent of the medical therapy and the results of the
delivered medical treatment to determine if the results from the
delivered therapy are within the parameters and limits of the intent of
the medical therapy. The feedback controller 42 also adjusts the closed
loop and partial closed loop settings of the ventilator 34 and/or
controls the display 30 of the ventilator controller 18 to display an
alarm condition when the results from the delivered medical therapy are
not within the parameters and limits of the intent of the medical therapy
to indicate that clinician intervention is required.

[0032] The control processor 26 of the ventilator controller 18 also
includes a processor 44, for example a microprocessor or other software
controlled device configured to execute semantic communication and
ventilator control software for performing the operations described in
further detail below. Typically, the semantic communication and
ventilator control software is stored in is carried on other tangible
memory or a computer readable medium 28 for execution by the processor.
Types of computer readable media 28 include memory such as a hard disk
drive, CD-ROM, DVD-ROM and the like. Other implementations of the
processor are also contemplated. Display controllers, Application
Specific Integrated Circuits (ASICs), and microcontrollers are
illustrative examples of other types of component which may be
implemented to provide functions of the processor. Embodiments may be
implemented using software for execution by a processor, hardware, or
some combination thereof.

[0033] The semantic communications includes arrays of primitives,
statements, event summaries, and event tags. The primitives are
constructed by identifying a driving function for each therapy epoch, an
optimizing function for the therapy epoch, and accepted functions for the
therapy epoch. The statements are constructed from each base function
which contains an implicit or explicit statement with enumeration or a
conditional statement relating to the therapy epoch. The statements also
contain the transfer function information relating to the primitives. The
event summaries each include an intended and delivered or resulting
component. The event summaries are generated from the primitives and
statements. The event tag includes an event type tag which is based on
either a harmonized naming standard or manufacture's declaration.

[0034] With reference to FIGS. 2A-2D, the semantic communications includes
an event tag 100, with a unique reference to each event reported (breath
ID) such as patient breath, and a mode of operation 102 of the medical
device delivering the medical therapy. As used herein, mode of operation
signifies the different methods, patterns, or modes that the medical
therapy devices deliver, including continuous positive airway pressure,
synchronized intermittent machine ventilation, and the like. The semantic
communications also include the intent of the medical therapy 104 and the
result of the delivered medical therapy 106. The intent of the medical
therapy 104 includes data relating to the medical therapy device, such as
the delivered oxygen volume, flow rate, pressure, medical therapy device
settings, and the like being delivered to the patient on the ventilator.
The intent of the medical therapy 104 also includes data relating to the
patient, such as how the selected primitives should relate to each other,
acceptable ranges, and how the selected primitives should vary with
changes in the patient's physiological state, and the like. The result of
the delivered medical therapy 106 includes data relating to the patient's
physiological state and the medical therapy device's delivery results,
such as the output pressure, flow and volume of the ventilator.

[0035] To facilitate computation of the physiologic applications, modes,
variables, control loops, and the like, that can be defined as transfer
functions, for example, as components in Laplace Transforms of partial
differential equations representing temporal relationships among
pressure, flow, and volume. For example, objective breath shapes may be
defined based on demographic and/or morbidity types or attributes, such
as adult, pediatric, or neonatal characteristics; or COPD (Chronic
Obstructive Pulmonary Disease) profiles based on salient parameters such
as pulmonary mechanics, physiologic system response, and patient effort.

[0036] FIG. 2A and 2C illustrates an example of a semantic communication
for a ventilator providing continuous positive airway pressure in a CPAP
mode. In this example, the driving function is airway pressure. The
driving function is delivered by the optimizing function or the machine
gas flow in this example. The resulting function is patient expired
volume. The semantic communication also indicates that the patient
initiates each breath (i.e. there is no machine cycling based on
delivered pressure or volume).

[0037] FIGS. 2B and 2D illustrate examples of semantic communications for
ventilators providing synchronized intermittent machine ventilation. In
these examples, the ventilator is programmed to deliver a certain number
of volume cycled breaths per minute to a maximum permissive pressure with
a predefined flow pattern. When the machine breath is not intended the
patient is allowed to breathe as if they were on basic CPAP, i.e.,
patient initiated breathing. Conditional and/or context-sensitive
statements may be included as needed to accommodate configuration
variations such as "Automatic Tube Compensation (ATC)".

[0038] FIG. 3 illustrates operation of the treatment delivery system. In a
step 200, a therapy objective or intent of the medical therapy is
inputted by a clinician. In a step 202, the therapy objective is ordered
by the clinician and transmitted to a supervisory control. In a step 204,
the therapy objective is verified by the supervisory control. In a step
206, the supervisory control initiates the settings of the medical
therapy device for the therapy objective. In a step 208, the operational
settings are inputted into the medical therapy device for the therapy
objective. The operational settings are utilized to support the medical
therapy device in delivering the medical therapy in a step 210. In a step
212, the pulmonary mechanics and physiological systems are monitored to
determine the results of the delivered medical therapy. The operational
settings of the medical therapy device are then adjusted based on the
delivery results of the medical therapy in order to deliver the medical
therapy within the parameters and limits of the therapy objective in a
step 214. In a step 216, observation alarms generated if the delivery
results of the medical therapy are outside the parameters and limits of
the therapy objective are transmitted to the supervisory control.

[0039]FIG. 4 illustrates operation of the treatment delivery system. In a
step 300, a therapy objective or intent of the medical therapy is
inputted by a clinician. In a step 302, the therapy objective is
transmitted to a therapy advisor which recommends a proper medical
therapy for the therapy objective. In a step 304, the medical therapy is
transmitted to a supervisory control. In a step 306, the supervisory
control adjusts the settings of the medical therapy device for the
medical therapy. In a step 308, the pulmonary mechanics and physiological
systems are monitored to determine the results of the delivered medical
therapy. Observation alarms are generated if the delivery results of the
medical therapy are outside the parameters and limits of the therapy
objective in a step 310. The observation alarms are transmitted to the
therapy advisor, the supervisor control, and partial closed loop and
closed loop settings. In a step 312, the partial closed loop settings are
adjusted based on the delivery results of the medical therapy in order to
deliver the medical therapy within the parameters and limits of the
therapy objective. In a step 314, the closed loop settings are adjusted
based on the delivery results of the medical therapy in order to deliver
the medical therapy within the parameters and limits of the therapy
objective from breath to breath as well as over the long term, e.g.,
entropy can be tracked and controlled.

[0040] With reference to FIG. 5, each therapy epoch may have multiple
feedback paths which are independent from each other but are coupled and
optimized, Here a plurality of data inputs 400 including a fractional
inspired oxygen concentration, peak inspiratory pressure, plateau
pressure, peak end expiratory pressure, clinical information, laboratory
information, medication administration, historical physiological and
other health record information, and the like are inputted into a
ventilator feedback controller 402. The data inputs 400 are utilized by a
ventilation optimization loop 404 to optimize the operational settings of
the ventilator in order to provide the proper medical therapy based on
the data inputs 402 and intent of the therapy. The ventilation
optimization loop 404 outputs a plurality of data outputs 406 including a
fractional inspired oxygen concentration, an end tidal carbon dioxide
concentration, and the like to a oxygenation optimization loop 408 which
optimizes the oxygenation of the ventilator in order to provide the
proper medical therapy based on the data inputs 402. For example, a
clinical decision system 403 is included, e.g., including a decision
tree, which maps the patient's improving or deteriorating physiological
state to appropriate evolving treatment levels. The ventilation
optimization loop 404 also outputs a tidal volume. The tidal volume 410
is combined with a minute volume 412 of the ventilator and input along
with the data outputs 406 to the oxygenation optimization loop 408. A
plurality of physiological parameters 414 including pH, a saturation
level of oxygen, a partial pressure of CO2, a fractional inspired oxygen
concentration, an end tidal carbon dioxide concentration, and the like,
of the patient resulting from the delivered medical therapy are then
inputted to ventilation optimization loop 404 which then optimizes the
operational settings of the ventilator in order to provide the proper
medical therapy based on the physiological parameters 414.

[0041] The invention has been described with reference to the preferred
embodiments. Modifications and alterations may occur to others upon
reading and understanding the preceding detailed description. It is
intended that the invention be constructed as including all such
modifications and alterations insofar as they come within the scope of
the appended claims or the equivalents thereof.